InflammationPhase 1NCT01038674
Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis
A Phase 1 study testing anti-IL-20 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 2 sites in 2 countries.
Trial summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammation, Rheumatoid Arthritis
- What is being tested?
- anti-IL-20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2010to Dec 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent obtained before any trial-related activities
- A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
- Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
- Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
- Male subjects and female subjects of non-child bearing potential
Who cannot join
- Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
- Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
- Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
- Past or current malignancy (as judged by the investigator)
- Clinically significant cardiac or cardiovascular disease
Show all 9Show fewer
- Positive for human immunodeficiency virus (HIV), hepatitis or tuberculosis
- Blood donation or blood loss of more than 0.45L within 2 months prior to study start, or longer if required by local regulations
- Breast-feeding women
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.
- Conditions
- Inflammation, Rheumatoid Arthritis
- Being tested
- anti-IL-20, placebo
- Medical subject headings
- Inflammation, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-IL-20Drug
Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
placeboDrug
Placebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Anti-IL-20 | Experimental | Not described Receives: Drug: anti-IL-20 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 0 - 21 weeks after dosing
Secondary outcomes (3)
Terminal serum half-life
Measured: 0 - 21 weeks after dosing
Maximum observed serum concentration (Cmax)
Measured: 6 - 10 weeks after dosing
Change in ACR20, ACR50 and ACR70
Measured: 0-21 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038674
- Sponsor's protocol ID
- NN8226-3704
- Other IDs
- 2009-013132-20, U1111-1112-6382, 2009
- Status last verified
- Feb 2017
- First submitted
- 22 Dec 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
PubMed 25749867
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Dose-escalation, Phase 1 Trial of Anti-IL-20 in Subjects With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01038674
- Acronym / sponsor ID
- NN8226-3704
- Conditions
- Inflammation, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and tolerability of the drug Anti-IL-20 in subjects with rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-IL-20 | Experimental | Drug: anti-IL-20 |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent obtained before any trial-related activities
- A diagnosis of rheumatoid arthritis made at least 3 months prior to screening
- Active rheumatoid arthritis, characterised by a DAS28 equal or above 3.2
- Methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included)
- Male subjects and female subjects of non-child bearing potential
Key exclusion criteria (9 listed)
- Body mass index (BMI) less than 18.5 or above 35.0 kg/m2
- Subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis
- History of or current inflammatory joint disease other than rheumatoid arthritis
- Chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start
- Past or current malignancy (as judged by the investigator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-IL-20Anti-IL-20 injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels. | Drug | Anti-IL-20 |
| placeboPlacebo injected subcutaneously (under the skin) with 1 dose once weekly during a 6 week period (in total 7 doses) at 2 dose levels. | Drug | Placebo |
Primary outcome
Adverse events
Time frame: 0 - 21 weeks after dosing
3 secondary outcomes
Terminal serum half-life
Time frame: 0 - 21 weeks after dosing
Maximum observed serum concentration (Cmax)
Time frame: 6 - 10 weeks after dosing
Change in ACR20, ACR50 and ACR70
Time frame: 0-21 hours after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Results publication: PubMed 25749867Lundblad MS, Overgaard RV, Gothberg M, Fjording MS, Watson E. Clinical pharmacokinetics of the anti-interleukin-20 monoclonal antibody NNC0109-0012 in healthy volunteers and patients with psoriasis or rheumatoid arthritis. Adv Ther. 2015 Mar;32(3):228-38. doi: 10.1007/s12325-015-0191-7. Epub 2015 Mar 7.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-IL-20 in people with Inflammation and Rheumatoid Arthritis, run by Novo Nordisk A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 0 - 21 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.